HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1 BESLUIT

Op 19 december 2018 is van BASF Nederland B.V.

Postbus 1019 6801 MC ARNHEM

een aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating ontvangen voor het middel

Sercadis

op basis van de werkzame stof fluxapyroxad.

HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel.

Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit.

Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen:

- Bijlage I voor details van de aanvraag en toelating.

- Bijlage II voor de etikettering.

- Bijlage III voor wettelijk gebruik.

- Bijlage IV voor de onderbouwing.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende

aanduidingen en vermeldingen op de verpakking te worden vermeld:

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- Het toelatingsnummer met een cirkel met daarin de aanduiding van de W-codering zoals vermeld onder “toelatingsinformatie” in bijlage I bij dit besluit.

- De etikettering zoals opgenomen in bijlage II bij dit besluit.

- Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III bij dit besluit.

- Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt.

2 WETTELIJKE GRONDSLAG

Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en artikel 2.2 Rgb Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009

Gebruikt toetsingskader Conform Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual Zonaal.

3 BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof wijzigen niet.

3.2 Analysemethoden

De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten toepassingen voldoen de vereiste residuanalysemethoden.

3.3 Risico voor de mens

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid

Gelet op artikel 51 Verordening (EG) 1107/2009 is de aanvraag niet beoordeeld voor het aspect

werkzaamheid (inclusief fytotoxiciteit).

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gewasbeschermingsmiddelen en biociden, voor deze:

de voorzitter,

Ir. J.F. de Leeuw

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BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

1 Aanvraaginformatie

Aanvraagnummer: 20182580 NLKUG

Type aanvraag: aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating

Middelnaam: Sercadis

Formele registratiedatum: * 27 januari 2019 Datum in behandeling name: 4 april 2019 Datum compliance check: N.v.t.

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

2 Stofinformatie

Werkzame stof Gehalte

fluxapyroxad 300 G/L

De stof is per 1 januari 2013 goedgekeurd krachtens Verordening (EG) No 1107/2009 (Reg. (EU) No 589/2012 d.d. 4 juli 2012), met expiratiedatum 31 december 2022.

3 Toelatingsinformatie

Toelatingsnummer: 15126 N

Expiratiedatum: 31 december 2023

Afgeleide of parallel: n.v.t.

Biocide, gewasbeschermingsmiddel of toevoegingsstof:

Gewas

Gebruikers: Professioneel

W-codering professioneel gebruik: W2

4 Aflever- en opgebruiktermijnen voor oude etiket Vorige W-codering professioneel gebruik: W1 Aflevertermijn professioneel gebruik: nvt Opgebruiktermijn professioneel gebruik: nvt

5 Verpakkingsinformatie Aard van het preparaat:

Suspensie concentraat

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Gevarenaanduidingen H351 Verdacht van het veroorzaken van kanker.

H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen.

Voorzorgsmaatregelen P201 Alvorens te gebruiken de speciale aanwijzingen raadplegen.

P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen.

P308 + P313 Na (mogelijke) blootstelling: een arts raadplegen.

P391 Gelekte/gemorste stof opruimen.

P405 Achter slot bewaren.

P501 Inhoud/verpakking afvoeren naar ....

SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.

Aanvullende etiketelementen

EUH208 Bevat 1,2-benzisothiazool-3(2H)-on. Kan een allergische reactie veroorzaken.

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke

gezondheid en het milieu te voorkomen.

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel

Wettelijk Gebruiksvoorschrift

Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden.

Toepassingsgebied Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Maximaal aantal liter middel per ha per 12

maanden

Minimum interval tussen

toepassingen in dagen

Veiligheidstermijn in dagen

Pitvruchten Schurft

¹

0,25 – 0,3 L/ha 3 0,9 L/ha 7 35

Echte meeldauw

²

0,25 L/ha

1

Schurft (Venturia inaequalis, Venturia pirina)

2

Echte meeldauw (Podosphaera leucotricha)

Het gebruik in de teelt van druif is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing geen werkzaamheids- en

fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in dit toepassingsgebied, komt voor risico en verantwoordelijkheid van de gebruiker

Toepassingsgebied Te bestrijden organisme Dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Minimum interval tussen

toepassingen in dagen

Veiligheidstermijn in dagen

Druif

(onbedekte teelt)

Echte meeldauw

³

0,15 L/ha 3 10 35

3

Echte meeldauw (Erysiphe necator)

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Om in het water levende organismen te beschermen is toepassing in de teelt van pitvruchten op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien voor 1 mei op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste de klasse DRT90.

Resistentiemanagement

Dit middel bevat de werkzame stof fluxopyroxad. Fluxopyroxad behoort tot de Succinate dehydrogenase remmers (SDHI). De Frac code is 7. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de

voorlichtingsboodschappen, op te volgen.

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE IV RISK MANAGEMENT

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Applicant : BASF Nederland BV Evaluator : Ctgb, NL

REGISTRATION REPORT Part A

Risk Management

Product code: Sercadis Active Substance:

fluxapyroxad 300 g/L (g/kg)

COUNTRY: The Netherlands

NATIONAL ASSESSMENT

Applicant: BASF Nederland BV

Date: June 2019

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Netherlands (risk envelope approach). The following sections of Registration Report, Part B were prepared on basis of new data (see also table below):

• Section 3: mammalian toxicology

Risk envelope overview:

section worst case critical GAP used covered by risk

envelope (decision) remarks

1

Identity, physical and chemical

not relevant for extension of

authorisation according Article 51. yes

2

analytical methods

formulation: not relevant for extension of authorisation according Article 51.

residues: are covered by the main authorisation.

yes for residues see: 3.1.2.2

3

mammalian toxicology Grapevine (wine, table) (F) no see special Part B.3 for this

section 4

metabolism and residues

See 3.1.4 no See 3.1.4

5

environmental fate covered by the main authorisation yes

6 ecotoxicological

studies

covered by the main authorisation yes

7

efficacy data

not relevant for extension of

authorisation according Article 51 n/a

8 relevance of metabolites in

groundwater

covered by the main authorisation yes

1 Details of the application

Application to extend the authorisation of a plant protection product (PPP) already authorised in The Netherlands to minor uses not yet covered by that authorisation.

The application is intended for use in The Netherlands only.

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1.1 Application background

Details on applicant and application Plant protection product Sercadis

Type of application National application according to Article 51 Registration number 15126 N

Applicant BASF Nederland B.V.

Authorisation holder Postbus 1019

6801 MC The Netherlands

Function Fungicide

Type of formulation Suspension Concentrate (SC) Expiration of authorisation 31/12/2023

1.2 Approval

The active substance included in the plant protection product is approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals.

Active substance Fluxapyroxad

Content in PPP 300 g/L

Approval status approved according Regulation (EC) No 1107/2009

Approval Regulation (EC) No 540/2011

Expiration of approval 31/12/2022

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1.3.1 Uses applied for and registration decision Please refer to GAP (2.3).

1.3.2 Public interest and minor use

According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest.

In The Netherlands the cultivated area of Grapevine falls within the areas that are indicated to be minor uses (= field use maximum 5.000 ha and indoor use max.1.000 ha).

1.4 Data protection claims

The applicant is owner of the new studies submitted and claims data protection.

1.5 Letters of Access

Not applicable.

2 Details of the authorisation

2.1 Product identity

Product name Sercadis

Authorisation number 15126 N

Composition Fluxapyroxad pure 300 g/L Type of formulation Suspension Concentrate (SC)

Function Fungicide

Authorisation holder BASF Nederland B.V.

Postbus 1019 6801 MC Arnhem 2.2 Classification and labelling

2.2.1 Classification and labelling under Regulation (EC) No 1272/2008

The classification and labelling of the original authorisation is maintained. Refer to the original authorisation (20130974 ZETG d.d. 03/06/2016).

2.2.2 R and S phrases under Regulation (EC) No 547/2011

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See 2.2.1

2.2.3 Other phrases

2.2.3.1 Restrictions linked to the PPP

Please refer to the original authorisation (20130974 ZETG d.d. 03/06/2016).

2.2.3.2 Specific restrictions linked to the intended uses

Some of the authorised uses are linked to the following conditions (mandatory labelling):

See Appendix 2 – Copy of the product label

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Active substance.…: - Conc. of as ….: -

Safener: - Conc. of safener: -

Synergist: - Conc. of synergist: -

Applicant: BASF Nederland BV Professional use: ☒

Non professional use: ☐

Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14

Use- No.

(e)

Member state(s)

Crop and/

or situation

(crop destination / purpose of crop)

F, Fn, Fpn G, Gn, Gpn or I

Pests or Group of pests controlled (additionally:

developmental stages of the pest or pest group)

Application Application rate PHI

(days)

Remarks:

e.g. g

safener/synergist per ha

(f)

Method / Kind

Timing / Growth stage of crop &

season

Max.

number a) per use b) per crop/

season

Min.

interval between applications (days)

kg or L product / ha a) max. rate per appl.

b) max. total rate per crop/season

g or kg as/ha a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha min / max

Minor uses according to Article 51 5 NL Grapevine

(wine, table) (VITVI)

F Erysiphe necator (UNCINE)

spraying BBCH 11-83 (April- September)

a) 3 b) 3

10 a) 0.15 b) 0.45

a) 0.045 b) 0.135

200- 1200

35

Remarks table heading:

(a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(b) Catalogue of pesticide formulation types and international coding system CropLife International Technical Monograph n°2, 6th Edition Revised May 2008

(c) g/kg or g/l

(d) Select relevant

(e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1

(f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

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Applicant : BASF Nederland BV Evaluator : Ctgb, NL Remarks

columns:

1 Numeration necessary to allow references

2 Use official codes/nomenclatures of EU Member States

3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use situation should be described (e.g. fumigation of a structure)

4 F: professional field use, Fn: non-professional field use, Fpn: professional and non- professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named.

6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated.

7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application

8 The maximum number of application possible under practical conditions of use must be provided.

9 Minimum interval (in days) between applications of the same product

10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products.

11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha).

12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be mentioned under “application: method/kind”.

13 PHI - minimum pre-harvest interval

14 Remarks may include: Extent of use/economic importance/restrictions

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Not relevant for extension of authorisation according Article 51.

3.1.2 Methods of analysis

3.1.2.1 Analytical method for the formulation

Not relevant for extension of authorisation according Article 51.

3.1.2.2 Analytical methods for residues

The proposed extension for use of Sercadis involves application on a crop that cannot be extrapolated from the current authorisation based on its crop group (matrix) and its MRL. However, the residue analytical methods, included in the List of Endpoints of the EFSA conclusion on the peer review of the active substance fluxapyroxad, are suitable for monitoring of the MRL’s. Therefore, the proposed extension remains within the existing risk envelope for the section residue analytical methods for food/feed of plant and animal origin.

The residue analytical methods for air, soil and water were accepted during the assessment which led to the original authorisation of Sercadis. This simplified extension does not give rise to re-assess these residue analytical methods.

The proposed extension for use of Sercadis is covered by the risk envelope of the existing authorisation for the section residue analytical methods.

3.1.3 Mammalian Toxicology Operator

The use requested within this application for extension with a minor use (Grapevine (wine, table) (F)) is not covered by the current authorisation. Therefore, a risk assessment was performed for the operator.

For fluxapyroxad, the EU-AOEL of 0.04 mg/kg bw/day was used. For the dermal absorption, a value of 1% for the concentrate and a value of 37% for the spray dilution has been used (for a spray dilution of 0.045 kg a.s./ha / 1200 L/ha = 0.0375 g/L, a dermal absorption percentage of 37% has been derived in the original authorisation).

Based on the risk assessment, the risk is acceptable for mechanical downward spraying without the use of personal protective equipment (PPE). Regarding mechanical upward spraying, manual downward

spraying and manual upward spraying, the risk is acceptable with PPE (gloves and coverall during application).

Bystander

Please, refer to the original authorisation. The uses applied for are within the risk envelope of the original

authorisation.

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Worker

Please, refer to the original authorisation. The uses applied for are within the risk envelope of the original authorisation.

3.1.4 Residues and Consumer Exposure

All data requirements are covered by the main authorisation except for the points mentioned within this section.

The application concerns an extension of minor use of the plant protection product Sercadis, an SC formulation containing fluxapyroxad as active substance, in table and wine grapes.

3.1.4.1 Residues

Grapes (cGAP-NL: 3 x 45 g/ha, int. 10 d, BBCH 11-83, PHI 35 d)

The submitted studies, including eight supervised residue trials in grapes, were already assessed in the frame of an MRL application (EFSA Journal 2015;13(9):4223). The intended GAP (3 x 45 g/ha, int. 10 d, BBCH 11-83, PHI 35 d) is less critical than the cGAP assessed by EFSA (3 x 60 g/ha, int. 10 d, BBCH 11-83, PHI 35 d). Since the applicant is owner of the studies, the data may be used to support the minor use extension. Based upon the available data, no MRL exceedance is expected.

The effect of processing was sufficiently addressed in the EFSA reasoned opinion as well.

Grapes are usually not fed to animals and they are not grown in rotation. Therefore, residues in animal commodities and rotational crops do not need to be addressed.

3.1.4.2 Consumer exposure

For the chronic consumer risk assessment, it is referred to the latest EFSA reasoned opinion in which all commodities to which fluxapyroxad may be applied are considered (EFSA Journal 2017;15(9):4975). The intended use in grapes was assessed by EFSA before, i.e. this use is covered by the reasoned opinion. The EFSA PRIMo rev. 2 was used for calculations.

A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest chronic intake was calculated to be 38% of the ADI (German child diet).

The acute consumer exposure was calculated using the HR value determined by EFSA in its reasoned opinion (EFSA Journal 2015;13(9):4223). The most critical commodity, table grapes, contributed to 8%

of the acute reference dose (ARfD).

In conclusion, no unacceptable risk to the consumer is expected when the product is applied according to the intended uses.

3.1.5 Environmental fate and behaviour

The new use of Sercadis applied for in grapevine has an equal (or lower) risk for persistence in soil, leaching to groundwater and emission to surface water and sediment as the already authorised uses.

No separate risk assessment is required.

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3.1.6 Ecotoxicology

The use applied for in grape vine was already included in the core dossier of the original authorisation, however as it was not intended for the Dutch market, the Dutch specific aspects (aquatic organisms, non- target arthropods and non-target plants) were not assessed.

The risk of the applied use in grapevine for the Dutch specific aspects is equal to or lower than the risk of the authorised uses with regard to the environment for the aspects aquatic organisms, non-target

arthropods, non-target plants and activated sludge. The existing restriction sentence can remain unchanged:

Om in het water levende organismen te beschermen, is toepassing in de teelt van pitvruchten op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien voor 1 mei op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste de klasse DRT90.

3.1.7 Efficacy

According to Article 51 of the Regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products does not need to be checked.

3.2 Conclusions

PPP Sercadis is already registered in The Netherlands according to Directive 91/414/EEC or Reg. (EC) No. 1107/2009 taking into account the Uniform Principles of Reg. (EC) No. 546/2011.

The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of use.

Based on the risk assessment, no unacceptable risks are anticipated for the unprotected operator considering mechanical downward spraying; no unacceptable risks are anticipated for the protected operator considering mechanical upward spraying, manual downward spraying and manual upward spraying. Considering bystanders/residents and workers, the uses applied for are within the risk envelope of the current authorisation.

The intended use in table and wine grapes will not result in residues above the MRLs set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues of fluxapyroxad is not expected. There is no special risk mitigation necessary which deviate from the existing registration.

Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended.

3.3 Further information to permit a decision to be made or to support a review of the

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conditions and restrictions associated with the authorisation None

Appendix 1 – Copy of the product authorisation

The final product authorisation in the Netherlands can be found on the Ctgb website:

www.ctgb.nl > choose English > Authorised products database > Search term: Sercadis

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organisme per toepassing toepassingen per 12 maanden

aantal liter middel per ha per 12

maanden

interval tussen toepassingen in dagen

dagen

Pitvruchten Schurft

¹

0,25 – 0,3 L/ha 3 0,9 L/ha 7 35

Echte meeldauw

²

0,25 L/ha

1

Schurft (Venturia inaequalis, Venturia pirina)

2

Echte meeldauw (Podosphaera leucotricha)

Het gebruik in de teelt van druif is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassing geen werkzaamheids- en

fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in dit toepassingsgebied, komt voor risico en verantwoordelijkheid van de gebruiker

Toepassingsgebied Te bestrijden organisme Dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Minimum interval tussen

toepassingen in dagen

Veiligheidstermijn in dagen

Druif

(onbedekte teelt)

Echte meeldauw

³

0,15 L/ha 3 10 35

3

Echte meeldauw (Erysiphe necator)

Toepassingsvoorwaarden

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In pitvruchten het middel toepassen in 150-1000 liter water per ha.

Draag geschikte beschermende kleding, handschoenen tijdens het aanmaken van de spuitvloeistof en het spuiten.

Behandelde gebieden niet zonder beschermende kleding en handschoenen betreden totdat de spuitvloeistof is opgedroogd.

Om in het water levende organismen te beschermen is toepassing in de teelt van pitvruchten op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien voor 1 mei op het gehele perceel gebruik wordt gemaakt van een techniek uit tenminste de klasse DRT90.

Resistentiemanagement

Dit middel bevat de werkzame stof fluxopyroxad. Fluxopyroxad behoort tot de Succinate dehydrogenase remmers (SDHI). De Frac code is 7.

Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in

de voorlichtingsboodschappen, op te volgen.

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Appendix 4 – Reference list

Annex point

Author Year Title

Source (where different from company)

Company, Report No.

GLP or GEP status (where relevant) Published or Unpublished

Data protection claimed Y/N

Owner Application number(s) submission for data protection

Date of submission application

Extra art 51 data protection claimed Y/N

Study used Y/N

Date of the consolidated data

protection

Short explanation extra data protection

(Extra) data protection applies?

KIIIA 2.1/1, 2.3.1/1, 2.4.2/1, 2.5.1/1, 2.5.2/1, 2.5.3/1, 2.6.1/1, 2.7.1/1, 2.7.4/1, 2.8.2/1, 2.8.3.1/1, 2.8.3.2/1, 2.8.5.2/1, 2.8.6.1/1, 2.8.8.2/1

Kroehl, T. 2010 a

BAS 700 F 300 g/L SC - physical and chemical properties of formula BAS 700 04 F - accelerated storage stability for up to 2 weeks at 54°C in HDPE packs BASF SE, Limburgerhof, Germany Fed.Rep.

2009/1119422 Yes

Unpublished

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3 months extra data protection

Yes New consolidated date:

03-09-2026 (20182580 NLKUG)

KIIIA 2.1/2

Kroehl, T 2012 a

BAS 700 F 300 g/L SC - chemical and physical stability of formula BAS 700 04 F when stored for up to 3 years in HDPE packs BASF SE, Limburgerhof, Germany Fed.Rep.

2012/1015960 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

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Applicant : BASF Nederland BV Evaluator : Ctgb, NL Unpublished

KIIIA 2.2.1/1, 2.2.2/1

Fischer 2010 a

Evaluation of physical and chemical

properties according to Directive 94/37/EC (Regulation (EC) No 440/2008)

BASF SE,

Ludwigshafen/Rhein, Germany Fed.Rep.

2009/1102207 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 2.3.3/1

Fisher 2010 a

Evaluation of physical and chemical

properties according to Directive 94/37/EC (Regulation (EC) No 440/2008)

BASF SE,

2009/1102207 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA Kroehl, T. 2010 a

BAS 700 F 300 g/L SC - physical and chemical properties of formula BAS 700 04 F - accelerated storage stability for up to 2 weeks at 54°C in HDPE packs

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(26)

Applicant : BASF Nederland BV Evaluator : Ctgb, NL Annex

point

protection

BASF SE, Limburgerhof, Germany Fed.Rep.

2009/1119422 Yes

Unpublished KIIIA

2.4.2/2, 2.5.2/2, 2.7.5/1, 2.8.2/2, 2.8.3.1/2, 2.8.3.2/2, 2.8.5.2/2, 2.8.6.1/2, 2.8.8.2/2, 4.1.3/1

Kroehl, T. 2012 a

BAS 700 F 300 g/L SC - chemical and physical stability of formula BAS 700 04 F when stored for up to 3 years in HDPE packs BASF SE, Limburgerhof, Germany Fed.Rep.

2012/1015960 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 2.9.1/1, 2.9.2/1

Reinmaan, S.

2013 a

Physical and Chemical Compatibility in Aqueous Tank Mixtures of BAS 700 04 F

BASF SE Agricultural Center Limburgerhof, Limburgerhof, Germany Fed.Rep.

2013/1110241 No

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 5.2.1/1

Bentz A., ²⁰⁰⁹ a

Quantitative determination of the

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive

Yes New

(27)

Siebecker M.

active ingredient Reg.No. 5 094 351 in BAS 700 04 F by HPLC

2009/1096910 No

Unpublished

1107/2009, 1 use = 3 months extra data protection

consolidated date:

03-09-2026 (20182580 NLKUG)

KIIIA 5.2.1/2

Bentz A. ²⁰⁰⁹ a

Validation of the analytical HPLC- method AFL0792/01:

Quantitative determination of the active ingredient BAS 700 F in BAS 700 04 F BASF SE,

Limburgerhof, Germany Fed.Rep.

2009/1096911 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 5.2.4/1

Siebecker M., Bentz A.

2010 a

Validation of analytical method APL0594/01:

Determination of toluene in BAS 700 F TGAI and formulation by GC/MS headspace BASF SE,

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(28)

point

protection

2009/1116595 Yes

Unpublished KIIIA

5.2.4/2

Bentz A., Siebecker M.

2010 a

Supplement of the analytical method APL0594/01:

Determination of toluene in BAS 700 F containing SC-, EC- and FS-formulations BASF SE,

2010/1021229 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 7.1.1/1

Cords S.- M.

Lammer E.-M.

2009 a

BAS 700 04 F: Acute oral toxicity study in rats

2009/1046046 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG) KIIIA

7.1.2/1

Cords S.- M.

Lammer E.-M.

2009 b

BAS 700 04 F: Acute dermal toxicity study in rats

2009/1046047 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG) KIIIA

7.1.3/1

Wittmer E.

Landsiedel 2010 a

BAS 700 04 F - Acute inhalation toxicity study

Yes BASF 20130974

ZTG

Yes New

(29)

R. in Wistar rats - 4-Hour liquid aerosol exposure (head-nose only) 2010/1014827 Yes

Unpublished

consolidated date:

03-09-2026 (20182580 NLKUG) KIIIA

7.1.4/1

Wolf T. ²⁰⁰⁹ a

BAS 700 04 F: Acute dermal irritation / corrosion in rabbits 2009/1107323 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG) KIIIA

7.1.5/1

Wolf T. 2009 b

BAS 700 04 F: Acute eye irritation / corrosion in rabbits

2009/1107321 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG) KIIIA

7.1.6/1

Wieland J. 2012 a

BAS 700 04 F - Local lymph node assay (LLNA) in mice (CBA/CaOlaHsd) 2011/1140866 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG) KIIIA

7.6.2/1

Hassler S. 2012 a

BAS 700 F:

Percutaneous penetration of [14C]- BAS 700 F formulated as BAS 700 04 F (seed

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3 months

03-09-2026

(30)

point

protection

treatment) through human split-thickness skin membranes (in- vitro)

2012/1258143 Yes

Unpublished

extra data protection

(20182580 NLKUG)

KIIIA 7.6.2/2

Hassler S. 2012 b

First amendment to report - BAS 700 F:

Percutaneous penetration of [14C]- BAS 700 F formulated as BAS 700 04 F (seed treatment) through human split-thickness skin membranes (in- vitro)

2012/1261427 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 7.6.2/3

Hassler S. ²⁰¹² c

BAS 700 F:

Percutaneous penetration of [14C]- BAS 700 F formulated as BAS 700 04 F (fruit growing) through human split-thickness skin membranes (in vitro)

2012/1124291 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(31)

KIIIA 8.2/1

Grosshans, F,

Schopfer, C. Bross, M.,

Kuhnke, G.

2010 Metabolism of 14C- BAS 700 F in wheat after seed treatment application.

2010 Report: 8.2/1 Document No: BASF DocID 2009/1112531 GLP: Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 8.3.1/1

Kramm R. ²⁰¹³ a

Study of the residue behaviour of BAS 700 F after application in the furrow before planting and on the seed potatoes directly after planting with BAS 700 04 F under field conditions in United Kingdom, Belgium, Netherlands and Germany, 2011 BASF SE, Limburgerhof, Germany Fed.Rep.

2012/1137316 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 8.3.1/1a

Kramm R. 2014 a

Study of the residue behaviour of BAS 700 F after application in the furrow before

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3

(32)

point

protection

planting and on the seed potatoes directly after planting with BAS 700 04 F under field conditions in United Kingdom, Belgium, Netherlands and Germany, 2011 BASF SE, Limburgerhof, Germany Fed.Rep.

2014/1144354 yes

Unpublished

months extra data protection

03-09-2026 (20182580 NLKUG)

KIIIA 8.3.1/2

Schaeufele M.

2012 a

BAS 700 04 F:

Residue Study (at harvest) with BAS 700 04 F applied in the furrow directly before planting and on the seed potatoes directly after planting in Southern France, Greece, Italy and Spain in 2012 Huntingdon Life Sciences Ltd., Eye Suffolk IP23 7PX, United Kingdom 2012/1352716 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(33)

KIIIA 8.3.1/3

Kramm R. ²⁰¹³ b

Study on the residue behaviour of Fluxapyroxad in potatoes after treatment of the seed potatoes with BAS 700 04 F and planting under field conditions in Germany, Southern France and Spain, 2012

2013/1036304 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 8.3.2/1

Erdmann H.-P.

2011 a

Study on the residue behaviour of BAS 700 F in pome fruits after application of BAS 700 04 F under field condition in France, UK, Greece, Italy, Spain and Germany, 2010

Agro-Check Dr.

Teresiak & Erdmann GbR, Lentzke, Germany Fed.Rep.

2011/1050130 Yes

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(34)

point

protection

Unpublished KIIIA

8.3.2/2

Erdmann H.-P.

2012 a

Study on the residue behaviour of BAS 700 F in pome fruits after application of BAS 700 04 F under field condition in France (North and South), United Kingdom, Greece, Italy, Spain and Germany, 2011 Agro-Check Dr.

Teresiak & Erdmann GbR, Lentzke, Germany Fed.Rep.

2012/1150988 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 8.3.3/1

Schulz H. 2011 a

Study on the residue behaviour of Fluxapyroxad (BAS 700 F) in wine grapes after treatment with BAS 700 04 F under field conditions in Northern France, Germany, Italy, Spain and Southern France, 2010

SGS Institut Fresenius GmbH, Taunusstein,

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(35)

Germany Fed. Rep.

2011/1175006 Yes

Unpublished KIIIA

8.3.3/2

Meyer M. ²⁰¹² a

Study on the residue behaviour of BAS 700 F (Fluxapyroxad) in wine and table grapes after treatment with BAS 700 04 F under field conditions in Germany, Northern France, Southern France, Italy and Spain, 2011

SGS Institut Fresenius GmbH, Taunusstein, Germany Fed. Rep.

2012/1084185 Yes

Unpublished

Yes BASF 20182580

NLKUG

19-12-2018 y Y 05-07-2020 Article 59 directive 1107/2009, 1 use = 3 months extra data protection

05-10-2020

KIIIA 8.5.3/1

Plier S. 2013 a

Determination of residues of BAS 700 F (Fluxapyroxad) in apples and their processed products after three applications of BAS 700 04 F in Germany, 2012 BioChem agrar Labor fuer biologische und chemische Analytik

Yes BASF 20182580

NLKUG

19-12-2018 y Y 05-07-2020 Article 59 directive 1107/2009, 1 use = 3 months extra data protection

05-10-2020

(36)

point

protection

GmbH, Gerichshain, Germany Fed.Rep.

2013/1037953 Yes

Unpublished KIIIA

8.5.3/2

Jordan J.M., Saha M.

2009 a

Magnitude of BAS 700 F residues in apple processed fractions following applications of BAS 700 AE F BASF Agricultural Research Center, Research Triangle Park NC, United States of America

2009/7003644 yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 8.5.3/3

Belcher T.I., Riley M.

2012 a

Magnitude of

Fluxapyroxad residues in grape processed fractions following applications of BAS 700 04 F to grapes Eurofins Agroscience Services Inc., Forsyth GA, United States of America

2012/7000115 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(37)

KIIIA 8.5.3/4

Johnston R.L., Saha M.

2010 a

Magnitude of BAS 700 F residues in root and tuber processed fractions following applications of BAS 700 AE F

BASF Agricultural Research Center, Research Triangle Park NC, United States of America

2009/7003454 yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.1.6/1

Zok S. 2012 a

BAS 700 04 F - Acute toxicity in the bobwhite quail (Colinus

virginianus) after single oral administration (LD50)

BASF SE,

2011/1286218 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.2.2.1/1

Salinas E. 2009 a

BAS 700 04 F: Acute toxicity study in the rainbow trout (Oncorhynchus mykiss) BASF SE,

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3 months extra data

03-09-2026 (20182580

(38)

point

protection

2009/1120235 Yes

Unpublished

protection NLKUG)

KIIIA 10.2.2.1/2

Salinas E. 2010 a

BAS 700 04 F - Acute toxicity study in the common carp (wild type - Cyprinus carpio) BASF SE,

2010/1154436 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.2.2.2/1

Janson G.- M.

2010 a

Acute toxicity of BAS 700 04 F to Daphnia magna STRAUS in a 48 hour static test BASF SE, Limburgerhof, Germany Fed.Rep.

2009/1120198 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.2.2.2/2

Janson G.- M.

2010 b

Acute toxicity of BAS 700 04 F to Daphnia magna STRAUS in a 48 hour static test BASF SE, Limburgerhof, Germany Fed.Rep.

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(39)

2010/1197333 Yes

Unpublished KIIIA

10.2.2.3/1

Hoffmann F.

2010 a

Effect of BAS 700 04 F on the growth of the green alga

Pseudokirchneriella subcapitata BASF SE, Limburgerhof, Germany Fed.Rep.

2009/1116615 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.4.2.1/1

Zenker K. ²⁰⁰⁹ a

Acute toxicity of BAS 700 04 F to the honeybee Apis mellifera L. under laboratory conditions BioChem agrar Labor fuer biologische und chemische Analytik GmbH, Gerichshain, Germany Fed.Rep.

2009/1098875 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.4.2.2/1

Zenker K. 2009 a

Acute toxicity of BAS 700 04 F to the honeybee Apis mellifera L. under laboratory conditions

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3 months

03-09-2026

(40)

point

protection

BioChem agrar Labor fuer biologische und chemische Analytik GmbH, Gerichshain, Germany Fed.Rep.

2009/1098875 Yes

Unpublished

extra data protection

(20182580 NLKUG)

KIIIA 10.5.1/1

Fallowfield L.

2009 a

A rate-response laboratory test to determine the effects of BAS 700 04 F on the predatory mite, Typhlodromus pyri (Acari: Phytoseiidae) Mambo-Tox Ltd., Southampton SO16 7NP, United Kingdom 2009/1119430 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.1/2

Stevens J. 2009 a

A rate-response laboratory test to determine the effects of BAS 700 04 F on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae) Mambo-Tox Ltd., Southampton SO16 7NP, United Kingdom

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

(41)

2009/1119429 Yes

Unpublished KIIIA

10.5.2/1

Schmitzer S.

2011 a

Effects of BAS 700 04 F on the wolf spider Pardosa spec. in the laboratory - Extended laboratory study Institut fuer Biologische Analytik und

Consulting IBACON GmbH, Rossdorf, Germany Fed.Rep.

2011/1119839 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.2/2

Schmitzer S.

2011 b

Effects of BAS 700 04 F on the reproduction of rove beetles Aleochara bilineata - Extended laboratory study

Institut fuer Biologische Analytik und

Consulting IBACON GmbH, Rossdorf, Germany Fed.Rep.

2011/1119838 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.4/1

Graef D. ²⁰¹¹ a

A field study to evaluate the effects of

Yes BASF 20130974

ZTG

Yes New

(42)

point

protection

BAS 700 04 F on predatory mites (Acari:

Phytoseiidae) in an apple orchard in Germany - 3 early applications

Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Fed.Rep.

2010/1032751 Yes

Unpublished

consolidated date:

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.4/2

Graef D. 2011 b

A field study to evaluate the effects of BAS 700 04 F on predatory mites (Acari:

Phytoseiidae) in an apple orchard in Germany - 3 late applications

Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Fed.Rep.

2010/1032752 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.4/3

Graef D. 2011 c

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3

(43)

Phytoseiidae) in an apple orchard in Southern France - 3 early applications Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Fed.Rep.

2010/1032753 Yes

Unpublished

months extra data protection

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.4/4

Graef D. 2011 d

Phytoseiidae) in an apple orchard in Southern France - 3 late applications Eurofins Agroscience Services GmbH, Niefern-Oeschelbronn, Germany Fed.Rep.

2010/1032754 Yes

Unpublished

Yes BASF 20130974

ZTG

03-09-2026 (20182580 NLKUG)

KIIIA 10.5.4/5

Schwarz A. 2011 a

Effects of BAS 700 04 F on predatory mites (Acari: Phytoseiidae) under field conditions in orchard (3 early applications)

Yes BASF 20130974

ZTG

26-6-2013 Y 03-06-2026 Article 59 directive 1107/2009, 1 use = 3 months extra data

03-09-2026 (20182580